NCT05244304

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease

Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment of Stargardt Disease in Adolescent Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Belite Bio, Inc · Industry
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1

Detailed description

Approximately 90 subjects will be enrolled in this study. Subjects will be assigned to study drug (tinlarebant 5 mg/placebo) with treatment period of upto 24 months with 28 days of follow-up.

Conditions

• Stargardt Disease 1

Interventions

Type	Name	Description
DRUG	Tinlarebant	Tinlarebant drug substance is a white to off-white substance and is dispensed as a tablet for oral administration.
DRUG	Placebo	Not active drug

Timeline

• Start date: 2022-03-28
• Primary completion: 2025-08-04
• Completion: 2025-09-12
• First posted: 2022-02-17
• Last updated: 2025-10-31

Locations

19 sites across 11 countries: United States, Australia, Belgium, China, France, Germany, Hong Kong, Netherlands, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study